A Phase II, Multicenter, Open Label, Single Arm Study of SAR302503 in Subjects Previously Treated With Ruxolitinib and With a Current Diagnosis of Intermediate-2 or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

Status
Active
Cancer Type
Myelodysplastic Syndromes (MDS)
Trial Phase
Phase II
Eligibility
18 and over, Male and Female
Study Type
Biomarker/Laboratory analysis
Treatment
NCD ID
NCT01523171
Protocol IDs
ARD12181 (primary)
2011-005226-21
U1111-1124-0967
Study Sponsor
Sanofi-Aventis - US - Bridgewater

Summary

Primary Objective:

  • To evaluate the efficacy of once daily dose of SAR302503 in subjects previously treated with ruxolitinib and with a current diagnosis of intermediate-2 or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (Post-PV MF), or post-essential thrombocythemia myelofibrosis (Post-ET MF) based on the reduction of spleen volume at the end of 6 treatment cycles.

Secondary Objectives:

  • To evaluate the effect of SAR302503 on Myelofibrosis (MF) associated symptoms as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) diary
  • To evaluate the durability of splenic response
  • To evaluate the splenic response to SAR302503 by palpation at the end of Cycle 6
  • To evaluate the splenic response to SAR302503 through the first 6 treatment cycles
  • To evaluate the effect of SAR302503 on the Janus kinase 2 (JAK2) V617F allele burden
  • To evaluate the safety and tolerability of SAR302503 in this population
  • To evaluate plasma concentrations of SAR302503 for population PK analysis, if warranted

Objectives

The expected duration of the treatment in this study is approximately 8 months, based on a maximum 28-day screening period, followed by a 6-month (6-cycle) treatment period, and an EOT visit for subjects who will not continue the treatment after completing the 6 cycles of SAR302503, or discontinue the treatment early for any reasons as well as a follow-up visit which should occur 30 days after the last administration of SAR302503. Patients who continue to benefit clinically will be allowed to remain on study medication beyond the 6-month treatment period until the occurrence of disease progression or unacceptable toxicity.

Treatment Sites in Georgia


Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

Study Coordinator:
Shannon Gleason
404-778-4334

Doctors:

Elliott F. Winton MD